In the case, the plaintiffs filed cases against the Gilead pharmaceutical company over the company’s failure to bring an alternative medication used to treat AIDS, hepatitis, and other diseases to the marketplace called TAF under a speedier timeline, even though TAF and the originally developed medicine called TDF are both safe and are still effectively treating patients.
Click to download a copy of PRI’s amicus brief
PRI’s brief, which is authored by noted constitutional scholar and attorney Richard Epstein, notes that the pharmaceutical industry has been heavily regulated by government going back to 1902. The development of new medications by pharmaceutical companies is an expensive process and requires extensive testing and review. FDA approvals for new medications are denied about 88 percent of the time, often after “multiple, exhaustive submissions.”
“There has never been, until this misguided case,” notes PRI’s brief, “any effort by any state court to allow juries to impose vast damage awards, easily amounting many billions of dollars, because of their unguided, after-the-fact intuition that (Gilead) chose to develop and market a new set of highly successful drugs in the wrong sequence.”
While the plaintiffs acknowledge that no one has ever suggested that the FDA should withdraw TDF from the marketplace and that the drug “continues to be sold and promoted as safe and effective in both its proprietary and generic forms,” the PRI brief argues that the plaintiff lawyers in the case are offering “disputed individual factual claims of suffering from these bone and kidney side effects, for which they now demand millions in monetary compensation.”
The case law cited by the plaintiff’s lawyers, the PRI brief argues, effectively “hold that any given defendant can be found liable for some product-related injury that is not caused by a product defect.”
Challenging the assertions of the plaintiff’s lawyers, the brief counters that “the complaint charges that ‘Gilead withheld development of its safer product . . . (TAF), to artificially and unreasonably maximize profits on its TDF-based medications first.’”
However, the PRI brief argues, “what has happened is that these lawyers have brought an outrageous lawsuit to artificially and unreasonably maximize their personal profits with their TDF-based litigation (and) they do so notwithstanding the grave threat that their lawsuit poses to the discovery, production, and marketing of every pharmaceutical product.”
Allowing the case the go to trial, PRI’s brief concludes, would send “a strong signal to other pharmaceutical companies to swear off developing new drugs given the crushing liability that could follow their medical and commercial successes.”
